Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE

NCT ID: NCT06705387

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2027-03-31

Brief Summary

The goal of this clinical trial is to [primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.] in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]:

Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? Does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? Are comparative effective clinical trials feasible in this patient population?

Researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response.

Participants will be asked to:

• Be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily.
• Participate in 8 study visits over 52 weeks
• Complete questionnaires
• Have an endoscopy with biopsies and EndoFLIP measurements.
• Swallow an Esophageal String Test

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dupilumab (also known as Dupixent)

Group Type: ACTIVE_COMPARATOR

Dupilumab

Intervention Type: BIOLOGICAL

Subcutaneous injection of 300mg per week for 16 weeks.

fluticasone (also known as Flovent)

Group Type: ACTIVE_COMPARATOR

Fluticasone

Intervention Type: DRUG

Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.

Interventions

Dupilumab

Subcutaneous injection of 300mg per week for 16 weeks.

Intervention Type: BIOLOGICAL

Fluticasone

Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.

Intervention Type: DRUG

Other Intervention Names

Dupixent; Flovent

Eligibility Criteria

Inclusion Criteria

• Seen at CHCO for clinical care.
• Age 12 - 25 years old inclusive
• Weight ≥40 kg at the time of screening visit
• Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy
• Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.
• Evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm)

Exclusion Criteria

• Esophageal dilation performed at index endoscopy
• Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.
• Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.
• Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.
• Patients who have received dupilumab in the past 12 months for any indication are excluded.
• Diet restrictions and PPI use must stay unchanged in the 8 weeks prior to index endoscopy and through the study period.
• Patients with a fasting morning cortisol <5 within 2 months of screening will not be enrolled. If repeat cortisol levels are normal, patients can be reconsented.
• Known other esophageal disease or esophageal injury (e.g. achalasia, tracheoesophageal fistula, congenital stricture, caustic injury, history of esophageal surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder.
• Patients with a known gelatin allergy will be excluded from EST collection.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital Colorado/University of Colorado School of Medicine

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michelle Landis, BS

Role: CONTACT

michelle.landis@childrenscolorado.org

720-777-8884

Facility Contacts

Clinical Research Supervisor | Digestive Health Institute

Role: primary

michelle.landis@childrenscolorado.org

720-777-8884

Other Identifiers

1R01DK135692-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-2367

Identifier Type: -

Identifier Source: org_study_id